Status: Finalised
First registered on:
27/10/2015
Last updated on:
29/10/2018
1. Study identification
EU PAS Register NumberEUPAS11410
Official titleAsthma management in France and the United Kingdom
Study title acronym
Study typeObservational study
Brief description of the studyThis study will compare asthma management between patients in the United Kingdom and in France, in particular with regards to "at-risk" treatment patters. Two successive cohorts of persistent patients will be defined in 2007/2008 and in 2013/2014. Comparisons of asthma management between 2007 and 2013 will be made within countries to determine if there are any changes in "at-risk" management. Between countries, comparisons will be made to determine if there are differences in managements. For the latter analysis, only the 2013/2014 cohort will be used.
Was this study requested by a regulator?Don't know
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Dr
Last name Van Ganse
First name David
Is this study being carried out with the collaboration of a research network?
Yes
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?2
Countries in which this study is being conducted
International study
France
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/10/201501/10/2015
Start date of data collection30/10/201507/10/2015
Start date of data analysis02/11/201502/11/2015
Date of interim report, if expected
Date of final study report29/01/201613/10/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherClaude-Bernard-Lyon1 University100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Van Ganse
First name David
Address line 111 rue Guillaume Paradin
Address line 2
Address line 3
CityLyon
Postcode
CountryFrance
Phone number (incl. country code)33478778609
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Van Ganse
First name David
Address line 111 rue Guillaume Paradin
Address line 2
Address line 3
CityLyon
Postcode
CountryFrance
Phone number (incl. country code)33478778609
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
8. Population under study
Age
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects35000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Electronic Health Records (EHRs) enriched with PROs
11. Scope of the study
What is the scope of the study?
Risk assessment
asthma management comparison
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To compare asthma management between patients in the United Kingdom and in France, in particular with regards to at-risk treatment patterns.
Are there primary outcomes?Yes
Describe asthma managements with regards to the following:
1. LABA with no ICS prescription (Monotherapy)
2. Ratio units dispensed of LABA/ICS >= 2 (unit= canisters or prescriptions in the UK)
3. High use of SABAs (>= 12 canisters dispensed/prescribed)
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Historical observational, cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Asthma managements will be described with regards to the following:
1. LABA with no ICS prescription (Monotherapy)
2. Ratio units dispensed of LABA/ICS >= 2 (unit= canisters or prescriptions in the UK)
3. High use of SABAs (>= 12 canisters dispensed/prescribed)
Comparisons will be made:
1. Within country: This will compare asthma management in 2007/2008 vs 2013/2014
2. Between countries: Differences in management between countries
Treatment groups will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Inappropriate asthma therapy—a tale of two countries: a parallel population-based cohort study. Belhassen et al. npj Primary Care Respiratory Medicine volume 26, Article number: 16076 (2016)https://www.nature.com/articles/npjpcrm201676
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
